An interventional study of RiseTx in Prostate Cancer, Prostate Neoplasm and Cancer, sponsored by University of Illinois at Urbana-Champaign. Completed. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-25.
Sponsored by University of Illinois at Urbana-Champaign · Not applicable, Interventional, and Supportive care
The current study aimed to develop and assess an easy-to-use, highly accessible mobile and web-based application intervention to reduce sedentary behavior and increase physical activity in the hope of reducing the side effects of treatment and improving quality of life for the 13,000 or more prostate cancer survivors who are prescribed ADT each year in Canada. The study was conducted in two phases, where Phase one was focused on finding out about the attitudes and perceptions of sedentary behavior and the use of mobile applications among prostate cancer survivors using semi-structured interviews. Together with professional experts and a group of men who were diagnosed with prostate cancer, we developed RiseForTx - an application that is used on a smartphone or tablet to reduce time spent in, and to change patterns of, sedentary behaviour each day (Phase two). Part of the intervention was also focused on increasing daily steps to improve physical activity. We tested the intervention to examine (i) how the application works, (ii) if prostate cancer survivors like it and use it; and (iii) if sedentary behaviour and physical activity can reduce the impact of the side effects for treatment and improve quality of life among men on ADT.
In the first 10 days following recruitment, participants met with the research coordinator and were provided with an accelerometer (GT3X) and completed self-report baseline measures. Provided along with the RiseTx application is the Jawbone, which is a wrist-worn device that can assess activity patterns throughout the day and provide sensory alerts to stand after prolonged sitting (i.e., ≥30 minutes of sedentary time). The intervention consisted of five phases following initial data collection, including a baseline phase (weeks 1-2) where participants self-monitored their typical leisure time PA (i.e., step counts) and were asked to 'sync' their Jawbone with the RiseTx application to view their daily progress and steps. This daily self-monitoring process continued over the remaining intervention period. Based on a previously tested ramped step count approach that focuses on increasing walking by an extra 1000 daily steps over a set period, participants attempted to increase daily steps by 1000 over the average of their baseline week. Phases I-III involved progressive release of self-regulatory strategies (e.g., action planning) on the application and targeted changes in both sitting time (and breaks in sitting time) and step counts. Phase I (weeks 3-4) focused on increasing low intensity, incidental movement, through the use of an alerting device, and the Jawbone (reminder to break SED). At this time, an additional +1000 daily step increment was set above baseline. Phase II (weeks 5-6) targeted shorter planned PA (of up to 10 mins) by having participants form action plans on the application for both reducing SED and increasing PA. An additional +1000 daily step increment was set above Phase I. Phase III (weeks 7-8) focused on promoting longer, moderate intensity PA (>10 min), where participants used the application to form coping plans for barriers to reducing sitting time or engaging in PA. An additional +1000 daily step increment was set above Phase II step target. A 4-week consolidation phase (Phase IV and V; weeks 9-12) followed, where participants received weekly reminders that encouraged them to continue to use the RiseTx application to practice combining the different self-regulatory strategies learned in Phases I-III. Following the intervention, there was a 12-week maintenance period (weeks 13-24) where participants no longer received weekly self-regulatory practice reminders, yet still had access to the application.
7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.
This study's enrollment of 46 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Illinois at Urbana-Champaign is the lead sponsor of 191 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants were given access to the RiseTx application and an activity monitor to participate in the five phase intervention.
Other: RiseTx
Participants were given access to the RiseTx application, as well as given a Jawbone, a wrist-worn device that can assess activity patterns throughout the day and provide sensory alerts to stand after prolonged sitting (i.e., ≥30 minutes of sedentary time). The intervention consisted of five phases following initial data collection that comprised of self-regulatory strategies to reduce sitting time and self-monitoring of step counts.
Feasibility measures
Intervention adherence was tracked through website analytics such as number of logins (≥ 3 visits by participants each week to the RiseTx platform)
Time frame: 12 weeks
Physical Activity (PA)
PA was measured by ActiGraph Model GT3X accelerometers
Time frame: Baseline, 12 Weeks, 24 week follow-up
Step counts
Weekly step counts were collected using the Jawbone UP24.
Time frame: Baseline and 12 Weeks
Sedentary Behavior (SED)
Volume of SED was measured by ActiGraph Model GT3X accelerometers.
Time frame: Baseline, 12 Weeks, 24 week follow-up
Quality of life
Quality of life was assessed by the validated Functional Assessment of Cancer Therapy-General (FACT-G).
Time frame: Baseline, 12 Weeks, 24 week follow-up
Cancer-specific quality of life
FACT-Prostate contains 12 questions that assess the most important targeted symptoms and concerns for participants.
Time frame: Baseline, 12 Weeks, 24 week follow-up
Feasibility measures
Measurement completion was assessed by evaluating whether ≥75% of participants completed baseline, 12-weeks, and 24-week follow-up measures
Time frame: Baseline, 12 Weeks, 24 week follow-up
Feasibility measures
Acceptability was measured through an intervention satisfaction survey completed at post-intervention assessing perceptions and overall impressions of the RiseTx intervention (\>75% rate their participation as satisfactory or very satisfactory)
Time frame: 12 Weeks
Feasibility measures
Attrition was assessed by evaluating whether there was a ≤20% drop-out rate
Time frame: Baseline, 12 Weeks, and 24 week follow-up
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Illinois at Urbana-Champaign →